The FDA has received reports of 2 deaths and 24 serious injuries related to enteral misconnections just since 2011. It is thought that many enteral misconnections do not get reported to the FDA.

Several organizations, including the FDA, the International Organization for Standardization (ISO), The Joint Commission and enteral device manufacturers agreed on an enteral connection design that is compatible only with enteral devices. It is physically incompatible with IV, respiratory, urinary and other types of non-enteral devices. The connection design is called ISO 80369-3, more commonly known by the brand name, ENFit.

Although more than 80 California hospitals have transitioned to use of ENFit connectors for enteral devices, fewer hospitals have adopted the standard across the rest of the US. Many are in the planning stages, realizing that full adoption is a tedious process and may take several months. Find resources to help hospitals plan for and adopt ENFit here: http://stayconnected.org/tools-adopting-enfit/

On September 7, 2018 the FDA released a letter to manufacturers, healthcare professionals and hospital purchasing departments encouraging the use of 80369-3 or ENFit connectors in order to reduce risk of misconnection and patient injury. They provided the following recommendations.

Recommendations for Manufacturers:

Design safe enteral device connectors that are not compatible with non-enteral devices.